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CTRI Number  CTRI/2025/11/097304 [Registered on: 13/11/2025] Trial Registered Prospectively
Last Modified On: 13/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Assessment of likelihood ratio for four characteristic Carcinosin symptoms in Insomnia cases. 
Scientific Title of Study   Assessment of Likelihood Ratio for Four Characteristic Carcinosin Symptoms in Insomnia Cases 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr VARSHA KUMARI 
Designation  POST GRADUATE TRAINEE 
Affiliation  National Institute of Homoeopathy 
Address  Department of Homoeopathic Materia Medica, National Institute of Homoeopathy, OPD No 18, Block GE, Sector 3, Salt Lake, Kolkata

Kolkata
WEST BENGAL
700106
India 
Phone  7903064669  
Fax    
Email  varshakumfp@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr PRATIMA PAL 
Designation  ASSOCIATE PROFESSOR 
Affiliation  National Institute of Homoeopathy 
Address  Department of Homoeopathic Materia Medica, National Institute of Homoeopathy, OPD No 18, Block GE, Sector 3, Salt Lake, Kolkata

Kolkata
WEST BENGAL
700106
India 
Phone  7679507608  
Fax    
Email  dr.pratimapal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr PRATIMA PAL 
Designation  ASSOCIATE PROFESSOR 
Affiliation  National Institute of Homoeopathy 
Address  Department of Homoeopathic Materia Medica, OPD No 18, National Institute of Homoeopathy, Block GE, Sector 3, Salt Lake, Kolkata

Kolkata
WEST BENGAL
700106
India 
Phone  7679507608  
Fax    
Email  dr.pratimapal@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Homoeopathy, GE BLOCK, SECTOR 3, SALT LAKE, KOLKATA 700106  
 
Primary Sponsor  
Name  National Institute of Homoeopathy 
Address  National Institute of Homoeopathy, GE BLOCK, SECTOR 3, KOLKATA 700106 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr VARSHA KUMARI  National Institute of Homoeopathy  Department of Homoeopathic Materia Medica, OPD No 18, National Institute of Homoeopathy, Block GE, Sector 3, Salt Lake, Kolkata
Kolkata
WEST BENGAL 
7903064669

varshakumfp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NATIONAL INSTITUTE OF HOMOEOPATHY - INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F510||Insomnia not due to a substance orknown physiological condition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CARCINOSIN in insomnia cases   Doses: As required for patient Frequency: As per need of patient Route of administration: Oral Duration: 6 months  
Comparator Agent  Not applicable   Not applicable  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Participant suffering from insomnia verified by DSM5 criteria
Severity Clinical Insomnia Severity Index (ISI) score more than or equal to 14 (moderate to severe insomnia)
participants aged 18 to 60 years, all sexes.
Subjects of all socioeconomic status, all religions
Ability to understand either Bengali, Hindi, and or English
participants giving written consent to participate in this study
Subjects who agree to undergo laboratory investigation whenever required 
 
ExclusionCriteria 
Details  Participants with unstable psychiatric disorder like severe intellectual disability or autism with severe behavioral disturbances, substance-induced severe psychiatric disorders.
Pregnant women and lactating women.
Immune compromised state like HIV AIDS (low CD4 count), Cancer (hematologic or solid tumors) on active treatment, Chronic kidney failure (end-stage renal disease)
Concurrent medications: Use of hypnotics, sedatives, or stimulants that may interfere with sleep assessment.
Participants who has taken homoeopathic medicines for any chronic illness within 3 months. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the prevalence of selected symptoms of carcinosin in population that suffering from insomnia and improved by carcinosin ,assessment done through ISI [insomnia severity index].  At baseline 3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness of homoeopathic medicines in insomnia
To evaluate the effectiveness of carcinosin or other indicative medicine on quality of life through ORIDL [Outcome Related to Impact on Daily Living]. 
At baseline 3 months and 6 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
The patient’s information shall be recorded in a standardized case-taking proforma used in NIH, Kolkata (Appendix). Following preliminary screening for insomnia and detailed screening using the specified inclusion and exclusion criteria of the screening proforma (Appendix), eligible patients will be included in the study, followed by recording of baseline scoring data. All eligible patients presenting with insomnia will be prospectively evaluated for the presence of the four characteristic symptoms of Carcinosin, as identified from the Homoeopathic Materia Medica and verified by repertorisation (Appendix). The presence or absence of these characteristic symptoms in each case will be documented systematically. If the patient’s symptom totality shows similarity with Carcinosin and the characteristic symptoms are present, Carcinosin will be prescribed as the indicated remedy. If sufficient similarity is not found, other homoeopathic medicines will be prescribed according to individual indications. The final selection of the medicine will be based on detailed case taking in adherence with standard homoeopathic guidelines - including analysis and evaluation of symptoms, miasmatic diagnosis, framing of symptom totality, and final conclusion with reference to Homoeopathic Materia Medica (Appendix). Individualized dose and potency will be selected based on the susceptibility of the patient. Subsequent prescriptions will be generated in accordance with Kent’s observations on the second prescription and other relevant homoeopathic principles, and will be recorded in follow-up sheets (Appendix). The scoring data will be re-evaluated after 6 months of treatment. Based on the presence or absence of the four characteristic symptoms and the corresponding treatment outcomes, a 2×2 contingency table will be constructed to calculate the Likelihood Ratio (LR) for each characteristic symptom of Carcinosin in insomnia cases, thereby determining its prognostic value in remedy selection.
 
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